This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.
This is an open-label, single group, single dose study in subjects with nAMD or Macular Oedema Secondary to RVO. Screening and Day 1 can be performed on the same day. Subjects will receive ITV injection of SB11 PFS (0.5 mg ranibizumab in 0.05 mL) on Day 1, and follow up visit will be made on Day 1 (+2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection
SB Investigational Site
Katowice, Poland
SB Investigational Site
Krakow, Poland
SB Investigational Site
Olsztyn, Poland
Percentage of Successful Task Completions
Total of 12 tasks were evaluated, and the percentage of HCP's successful task completions were measured. Participating HCPs were allotted sufficient time to review the instructions for use (IFU) before preparing and administering the ITV injection on Day 1. HCP participants did not receive any additional training for the SB11 PFS prior to or during the study. "Percentage of successful task completions" was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the primary endpoint was the percentage of successful tasks completion among total attempts in this study.
Time frame: Day 1
Percentage of Successful Completion on Critical Tasks
Total of 6 tasks were considered as critical task, and the percentage of HCP's successful completion on critical tasks were evaluated. "Percentage of successful task completions" was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the secondary endpoint was the percentage of successful critical tasks (total of 6) completion among total attempts in this study.
Time frame: Day 1
Percentage of Successful Completion on Essential Tasks
Total of 6 tasks were considered as essential task, and the percentage of HCP's successful completion on essential tasks were evaluated. "Percentage of successful task completions" was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the secondary endpoint was the percentage of successful essential tasks (total of 6) completion among total attempts in this study.
Time frame: Day 1
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